MAUDE Adverse Event Report: OXFORD PERFORMANCE MATERIALS, INC. HTR-PEKK; CRANIAL IMPLANT

Model Number PK622571

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hair Loss (1877); Tissue Breakdown (2681)

Event Date 01/27/2021

Event Type  Injury  

Event Description

Approximately 1 year followng implantation, the patient had developed a scab near the implantation site.Upon examination, surgeon found the patient had extensive thinning of the skin from the implant to the point of hair loss and skin breakdown in multiple locations.Implant was removed to reclose the scalp and to preclude further issues.Surgeon noted the area did not appear infected and there was no history of trauma.

Manufacturer Narrative

D4: unique identifier (udi) number.

• Brand Name: HTR-PEKK
• Type of Device: CRANIAL IMPLANT
• Manufacturer (Section D): OXFORD PERFORMANCE MATERIALS, INC.; 30 south satellite road; south windsor CT 06074
• MDR Report Key: 11262536
• MDR Text Key: 229799198
• Report Number: 3009582362-2021-00002
• Device Sequence Number: 1
• Product Code: GXN
• UDI-Device Identifier: 00910023922049
• UDI-Public: (01)00910023922049(10)206706
• Combination Product (y/n): N
• PMA/PMN Number: K121818
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: PK622571
• Device Lot Number: 206706
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other